Delving into the Latest Updates on Tarchominskie Zaklady Farmaceutyczne Polfa SA with Synapse

Overview

A review.Currently, in vivo-in vitro correlation (IVIVC) has become an effective tool to predict absorption behavior of various pharmaceutical dosage forms.IVIVC in conjunction along with biopharmaceutical classification system (BCS) is considered to be a more effective alternative tool in view of the classical bioavailability studies.The most popular and recognized type ov IVIVC are studies related to prolonged release oral dosage forms.The methodol. for these tests is widely defined by FDA guidelines.Examples of IVIVC's for other pharmaceutical dosage forms like immediate release oral or parenteral prolonged release preparations are still limited.Especially, in the case of immediate release oral forms it seems to be such because of the lack of criteria, defined methodol., tech. difficulties as well as troubles to find immediate release formulations comprising different extent of absorption.First, the examples of IVIVC for variable immediate release oral dosage forms were discussed along with the appropriate biopharmaceutical class and pharmacokinetic profile of an individual active substance.Proposed approaches were also analyzed in view of the estimation of their reliability.Moreover, some tech. aspects of the building of IVIVC were discussed with the emphasis on the tools, which were applied to establish a correlation (e.g., time scaling factor, kind of pharmacokinetic anal., medium, type of apparatus, dissolution procedure).Finally, the perspectives of IVIVC application for immediate release dosage forms as an alternative strategy to the bioavailability studies were estimated and then a proposal for the reliability criteria of IVIVC in the case of immediate release oral dosage forms was done.

Drug Research

Bioequivalence Study of 8 mg Ondansetron Film-coated Tablets in Healthy Caucasian Volunteers

Article

Author: Ksycińska, H. ; Wilkowska, E. ; Raszek, J. ; Gilant, E. ; Tarasiuk, A. ; Kaza, M. ; Troć, M. ; Leś, A. ; Piątkowska-Chabuda, E. ; Łazowski, T. ; Serafin-Byczak, K. ; Rudzki, P. ; Skowrońska-Smolak, M.

The aim of the study was to investigate the bioequivalence of a generic product of 8 mg film-coated tablets (test) to the branded product (reference) at the same strength in order to apply for regulatory approval. The secondary objective of the study was to compare the tolerability of both products. A double blinded, randomized, cross-over, 2-period, comparative study was conducted in healthy Caucasian volunteers under fasting conditions. A single oral dose administration of the test or reference product was followed by a 7-day wash-out period. The ondansetron concentration was determined using a validated high performance liquid chromatography with a UV detection method. The 90% confidence interval of the point estimate (test over reference products) for C(max) and AUC(0-t) fell within the 80.00-125.00% acceptance range. The results of the study indicate that the film-coated tablets of Ondatron 8 mg manufactured by Tarchomińskie Zakłady Farmaceutyczne Polfa S.A. (test product) are bioequivalent to those of Zofran manufactured by GlaxoSmithKline Export Ltd (reference product). Both products were well tolerated.

100 Deals associated with Tarchominskie Zaklady Farmaceutyczne Polfa SA

Login to view more data

100 Translational Medicine associated with Tarchominskie Zaklady Farmaceutyczne Polfa SA

Login to view more data